Single fold system for tissue approximation and fixation

ABSTRACT

A single fold system for tissue approximation and fixation is described herein. The devices are advanced in a minimally invasive manner within a patient&#39;s body to create at least one fold within a hollow body organ. The system comprises a tissue acquisition and folding device and a tissue stapling or fixation device, each of which is used together as a system. The acquisition device is used to approximate a single fold of tissue from within the hollow body organ and the stapling device is advanced through a main lumen defined through the acquisition device and is used to affix the tissue. The stapling device is keyed to maintain its rotational orientation relative to the acquisition device and to provide the user positional information of the stapling device. The acquisition device is also configured to provide lateral stability to the stapling device prior to the stapling device being clamped onto tissue.

This application is a division of U.S. Ser. No. 10/773,883 filed Feb. 5,2004 now abandoned, the entire contents of which are incorporated hereinby reference.

FIELD OF THE INVENTION

The present invention relates generally to medical apparatus andmethods. More particularly, it relates to devices and methods forapproximating portions of a hollow body organ, particularly a stomach,intestine, or other region of the gastrointestinal tract, while affixingthe tissue.

BACKGROUND OF THE INVENTION

In cases of severe obesity, patients may currently undergo several typesof surgery either to tie off or staple portions of the large or smallintestine or stomach, and/or to bypass portions of the same to reducethe amount of food desired by the patient, and the amount absorbed bythe gastrointestinal tract. The procedures currently available includelaparoscopic banding, where a device is used to “tie off” or constrict aportion of the stomach, vertical banded gastroplasty (VBG), or a moreinvasive surgical procedure known as a Roux-En-Y gastric bypass toeffect permanent surgical reduction of the stomach's volume andsubsequent bypass of the intestine.

Typically, these stomach reduction procedures are performed surgicallythrough an open incision and staples or sutures are applied externallyto the stomach or hollow body organ. Such procedures can also beperformed laparoscopically, through the use of smaller incisions, orports, through trocars and other specialized devices. In the case oflaparoscopic banding, an adjustable band is placed around the proximalsection of the stomach reaching from the lesser curve of the stomacharound to the greater curve, thereby creating a constriction or “waist”in a vertical manner between the esophagus and the pylorus. During aVBG, a small pouch (approximately 20 cc in volume) is constructed byforming a vertical partition from the gastroesophageal junction tomidway down the lesser curvature of the stomach by externally applyingstaples, and optionally dividing or resecting a portion of the stomach,followed by creation of a stoma at the outlet of the partition toprevent dilation of the outlet channel and restrict intake. In aRoux-En-Y gastric bypass, the stomach is surgically divided into asmaller upper pouch connected to the esophageal inflow, and a lowerportion, detached from the upper pouch but still connected to theintestinal tract for purposes of secreting digestive juices. A resectedportion of the small intestine is then anastomosed using an end-to-sideanastomosis to the upper pouch, thereby bypassing the majority of theintestine and reducing absorption of caloric intake and causing rapid“dumping” of highly caloric or “junk foods”.

Although the outcome of these stomach reduction surgeries leads topatient weight loss because patients are physically forced to eat lessdue to the reduced size of their stomach, several limitations exist dueto the invasiveness of the procedures, including time, use of generalanesthesia, time and pain associated with the healing of the incisions,and other complications attendant to major surgery. In addition, theseprocedures are only available to a small segment of the obese population(morbid obesity, Body Mass Index≧40) due to their complications, leavingpatients who are considered obese or moderately obese with few, if any,interventional options.

In addition to surgical procedures, certain tools exist forapproximating or otherwise securing tissue such as the stapling devicesused in the above-described surgical procedures and others such as inthe treatment of gastroesophageal reflux disease (GERD). These devicesinclude the GIA® device (Gastrointestinal Anastomosis devicemanufactured by Ethicon Endosurgery, Inc. and a similar product byUSSC), and certain clamping and stapling devices as described in U.S.Pat. Nos. 5,403,326; 5,571,116; 5,676,674; 5,897,562; 6,494,888; and6,506,196 for methods and devices for fundoplication of the stomach tothe esophagus for the treatment of gastroesophageal reflux disease(GERD). In addition, certain tools, such as those described in U.S. Pat.Nos. 5,788,715 and 5,947,983, detail an endoscopic suturing device thatis inserted through an endoscope and placed at the site where theesophagus and the stomach meet. Vacuum is then applied to acquire theadjacent tissue, and a series of stitches are placed to create a pleatin the sphincter to reduce the backflow of acid from the stomach upthrough the esophagus. These devices can also be used transorally forthe endoscopic treatment of esophageal varices (dilated blood vesselswithin the wall of the esophagus).

There is a need for improved devices and procedures. In addition,because of the invasiveness of most of the surgeries used to treatobesity and other gastric disorders such as GERD, and the limitedsuccess of others, there remains a need for improved devices and methodsfor more effective, less invasive hollow organ restriction procedures.

BRIEF SUMMARY OF THE INVENTION

A system for tissue approximation and fixation is described which may beused to approximate and/or tension at least one fold of tissue fromwithin a hollow body organ, such as the stomach, esophageal junction,and other portions of the gastrointestinal tract. Generally, the devicesof the system may be advanced in a minimally invasive manner within apatient's body, e.g., transorally, endoscopically, percutaneously, etc.,to create one or several divisions or plications within the hollow bodyorgan. Examples of placing and/or creating divisions or plications maybe seen in further detail in U.S. Pat No. 6,558,400; U.S. patentapplication Ser. No. 10/188,547 filed Jul. 2, 2002; and U.S. patentapplication Ser. No. 10/417,790 filed Apr. 16, 2003, each of which isincorporated herein by reference in its entirety. The system maycomprise at least a tissue acquisition and folding device and a tissuestapling or fixation device, each of which may be used together as asingle system.

The folder assembly may generally comprise, in part, a tissueacquisition assembly which may be used to initially acquire and/orapproximate at least one fold of the tissue. The acquisition assemblymay comprise a tensioning member and a pod member, each of which may beindependently articulatable to form a first compact configuration and asecond larger, expanded configuration. Each of the members may beconnected to respective first and second actuation rods on the distalend of a yoke member, which connects the pod members to an elongateworking body or shaft. The working body itself may be comprised of aplurality of aligned link members which are adapted to provide someflexibility to the working body and which defines a main lumenthroughout a length of the working body as well as through the handleconnected to a proximal end of the working body. Moreover, the workingbody may be covered by a sheath or a covering to enhance the lubricityof the shaft as well as to maintain the interior of the working bodyclear from body fluids and debris and seal the shaft to allowinsufflation of the target organ. Various materials may be utilized forthe sheath including various plastics, elastomers, latex, polyurethane,thermoplastics, e.g., PTFE, silicone, PVC, FEP, Tecoflex®, Pebax®, etc.,so long as they are preferably biocompatible.

At least one of the members, such as the pod member, may additionallydefine a vacuum chamber or opening into which the tissue may be drawnwithin. The opening of the vacuum chamber may be slotted along adirection parallel to a longitudinal axis of the working body;alternatively, the opening may be defined a variety of shapes, e.g.,oval, elliptical, etc., and furthermore may be offset such that it isdefined transverse to the longitudinal axis of the working body. Thedistal end of the pod member may have a flexible and/or atraumatic tipsuch as a blunt, rounded, or “bullet” tip, made from any number ofpolymers to facilitate the guidance of the acquisition assembly into thehollow body organ without damaging tissue along the way. One example ofa device utilizing two pod members is described in further detail inU.S. patent application Ser. No. 10/686,326 filed Oct. 14, 2003, whichis commonly owned and is incorporated herein by reference in itsentirety.

A guidewire may optionally be used with the folder assembly duringinitial deployment and positioning within the hollow body organ in amanner similar to a catheter for guiding the acquisition assembly to apredetermined position. The use of the guidewire may assist in initialplacement of the device transorally, either through the main lumen ofthe device or it can also be exchanged through a lumen in the tip of thepod member. Both of the members may each be adapted to pivot onrespective hinge members such that in a first compact configuration, thefirst and second pod members are immediately adjacent to one another.When desirably positioned within the hollow body organ, a vacuum forcemay be applied within a vacuum chamber defined within the pod membersuch that tissue enters within the vacuum chamber or opening. To assistin placement of the device, various indicators may be used. Forinstance, one or several indicators may be located directly on thedevice or indicators may be utilized with the device in relation toanatomical structures or landmarks. In one example, an orientationmarker may be placed at a point on the distal portion of the device thatis visible endoscopically and can be adjusted relative to structuressuch as the “z-line” of the gastroesophageal, i.e., the place where achange in color of the tissue from whitish (esophagus) to a salmon color(stomach) occurs delineating what is referred to as the squamocolumnarjunction, i.e., the point where the lining changes from esophageal(squamous) to stomach (columnar). Then, in moving to a second expandedconfiguration, one or both of the tensioning member and/or the podmember may be translated via actuation rods into opposing radialdirections from one another such that the tissue is drawn through thetensioning member by the pod member and approximated to create a fold oftissue. Once this tissue fold has been desirably created, the fixationassembly may be advanced distally through the main lumen of the folderassembly and positioned upon exiting the main lumen to become clampeddirectly over the folded tissue. It is also within the scope of thisdisclosure to actuate the members simultaneously, serially orsingularly.

One or more vacuum tubes may be routed through the length, or a partiallength, of the working body for communication with the pod member. Theproximal ends of the vacuum tubes may be connected to one or more vacuumpumps. Furthermore, the vacuum tubes may utilize braided materials,e.g., stainless steel or superelastic materials such as Nickel-Titaniumalloy, integrated throughout to prevent kinking or pinching of thetubes.

The fixation assembly comprises, in part, a manipulatable staplerassembly connected via a flexible shaft to a stapler handle. The staplerassembly itself generally comprises a staple cartridge housing withinwhich one or more staples are housed. A corresponding anvil ispositioned in apposition to the staple cartridge housing and may be usedto provide a staple closure surface when tissue to be affixed isadequately positioned between the staple cartridge housing and theanvil. With the stapler assembly connected at the distal end of aflexible shaft, a handle is connected at the proximal end of the shaft.The handle itself may allow the surgeon or user to hold and manipulatethe fixation assembly while articulating the stapler assembly between anopen and closed configuration. Moreover, the configuration of the handleallows the surgeon or user to actuate the stapler assembly as well asdeploy the staples from the staple cartridge housing.

In use, the fixation assembly may be advanced within the folder assemblymain lumen with the fixation assembly configured in a closedconfiguration. To maintain an orientation, i.e., rotational stability,of the fixation assembly relative to the folder assembly and theapproximated tissue, the fixation assembly may be configured to have ashape which is keyed to a cross-sectional area of the folder assemblymain lumen. The keyed configuration helps to ensure that as the fixationassembly is advanced through the folder assembly, that the staplerassembly is optimally positioned to be clamped over the tissue forfixation.

When the stapler assembly is advanced and has exited the main lumen ofthe working body, the staple cartridge housing may be actuated into anopen configuration when positioned between distally extending armmembers of a yoke to receive the tissue folded between the pod members.The yoke arm members are configured such that when the stapler assemblyis positioned therebetween, the stapler assembly is prevented fromrotating or bending out of alignment for tissue affixation, i.e., thelateral stability of the stapler assembly is maintained relative to theyoke and the tissue. The stapler assembly may then be advanced distallyover the folded tissue and clamped onto the tissue for deploying thestaples. To avoid damaging tissue surrounding the acquisition assembly,one or several insertion indicators may be defined along a portion offlexible shaft of the fixation assembly, preferably near a proximal endof the shaft, to aid the user in knowing when the stapler assembly maybe safely articulated while the fixation assembly is positioned withinthe working body, i.e., the longitudinal stability of the staplerassembly is maintained relative to the folder assembly. The indicatorsmay be configured to align with a proximal end of the folder handle tocorrespondingly indicate, e.g., a position of the fixation assemblyrelative to the folder assembly when the stapler assembly may be opened,and/or how far distally the fixation assembly may be advanced relativeto the folder assembly to engage the folded tissue, and when the devicesare in a “safe to clamp” mode (e.g., in position around the tissue).Such positional indicators may utilize mechanical features, such as astop or detent. In addition, the stapler assembly jaws my bespring-loaded open to assist insertion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a tissue folding and fixationassembly which may be advanced within a hollow body organ to reconfigurethe tissue from within.

FIGS. 2A and 2B show open and closed perspective views, respectively, ofthe tissue folding assembly, respectively, which may be used tomanipulate tissue.

FIG. 3 shows a perspective view of one variation of the tissue foldingassembly in which a guidewire may be used to facilitate deploymentand/or placement within a body.

FIGS. 4A and 4B show side views of a variation of the tissue foldingassembly in an open and closed configuration, respectively, where themembers may be configured to maintain a parallel configuration relativeto one another.

FIGS. 5A and 5B show open and closed perspective views, respectively, ofanother variation of the tissue folding assembly showing an attachmentregion.

FIG. 6 shows an end view of a closed tissue folding assembly.

FIG. 7 shows a perspective view illustrating in one variation how astapler assembly may be advanced through the main lumen of the workingbody.

FIGS. 8A to 8C show cross-sectional side views of rotatable valves whichmay be used control the vacuum force within the device.

FIGS. 9A and 9B show an end view of an acquisition assembly which hasbeen translated with respect to one another while adhering tissue.

FIG. 10A shows a partial assembly of the handle for the folder assembly.

FIG. 10B shows a detail view of an exploded assembly of anchoring mountsand a proximal portion of an actuation rod assembly.

FIG. 11 shows a side view of an alternative variation on a dual actuatorfolder assembly housing.

FIGS. 12A to 12C show side, end, and perspective views, respectively, ofa link which may serve as a transitional link between the folder handleand the working body.

FIGS. 13A to 13C show side, end, and perspective views, respectively, ofone variation of links which may be used to form at least part of theworking body.

FIG. 13D shows an end view of a link having cross-sections of some ofthe various internal lumens which may be routed through the workingbody.

FIGS. 14A to 14C show side, end, and perspective views, respectively, ofone variation of an end link which may be used as a terminal link of theworking body.

FIG. 15 shows an end view of a link with the fixation assemblypositioned within for advancement through the main lumen of the workingbody while maintaining a consistent orientation.

FIGS. 16A to 16C show top, cross-sectional side, and perspective views,respectively, of one variation of a yoke member.

FIGS. 17A and 17B show front and rear end views, respectively, of theyoke member of FIGS. 16A to 16C.

FIG. 18 shows a top view of a stapler cartridge assembly positionedbetween the arm members of the yoke.

FIGS. 19A and 19B show variations of the stapler assembly positionedbetween the yoke having varied open regions.

FIGS. 20A to 20C show top, end, and side views, respectively, of analternative angled hinge member for use with a tensioning and/or podmember.

FIGS. 21A to 21C show top and perspective views, respectively, of avariation of a yoke and hinge assembly.

FIG. 22A shows a perspective view of one variation of a top cover whichmay be used with the acquisition assembly.

FIG. 22B shows a cross-sectional view of an optional basket insertpositioned within a vacuum chamber and a top cover secured over thechamber.

FIGS. 23A and 23B show another variation of FIGS. 22A and 22B,respectively, where the top cover and/or pod member may have serrations.

FIGS. 24A to 24D show side, end, bottom, and perspective views,respectively, of an optional basket insert which may be placed withinthe vacuum chamber of the pod assembly.

FIGS. 25A and 25B show side views of a variation of the stapler assemblyin clamped and opened configurations, respectively.

FIGS. 26A and 26B show side views of a variation of a cam member whichmay be used to urge the stapler assembly open and close.

FIGS. 27A to 27C show cross-sectional side, front, and top views,respectively, of one variation of stapler assembly.

FIG. 27D shows a top view of the anvil of the stapler assembly.

FIG. 28 shows a side view of another variation of a stapler assemblyhaving serrations defined along its clamping surfaces.

FIG. 29A shows a top view of one variation of staple pushers positionedover corresponding staples.

FIG. 29B shows a detailed perspective view of one example of a staplepusher.

FIG. 29C shows a perspective view of one example of a wedge which may beconfigured to slide within the cartridge housing.

FIGS. 30A and 30B show cross-sectional side views of one variation of astapler handle and its associated controls.

FIGS. 31A and 31B show perspective views of another variation of theapproximation device having an actively or passively curved workingbody.

FIG. 31C shows a detail view of the actuation handle of the device inFIGS. 31A and 31B.

FIGS. 32A and 32B show perspective and end views, respectively, of avariation of and end cap or seal which may be used to cap the handle ofFIG. 31C.

FIG. 33 shows a perspective view of one variation in which an endoscopecan be retroflexed to view the results or progress of the tissueapproximation and/or fixation.

FIG. 34 shows a portion of a flexible shaft of a stapler assembly withseveral insertion indicators positioned through the main lumen of thehandle of the folder assembly.

DETAILED DESCRIPTION OF THE INVENTION

A system for tissue approximation and fixation is described which may beutilized for approximating tissue regions from within a hollow bodyorgan, such as the stomach, esophageal junction, and other portions ofthe gastrointestinal tract. The system may be advanced within a bodythrough a variety of methods, e.g., transorally, transanally,endoscopically, percutaneously, etc., to create one or several divisionsor plications within the hollow body organ. At least two devices may beutilized as part of the system, a tissue acquisition and folding systemand a tissue stapling or fixation system, although it is contemplatedthat both devices can be integrated into a single mechanism. Each ofthese devices may be configured to efficiently operate with one anotherto provide optimal methods and devices for at least acquiring,approximating, and stapling regions of tissue from within the hollowbody organ in a minimally invasive manner.

Turning now to the figures, the system will first be described generallyin which one variation of system 10 is shown in FIG. 1, whichillustrates a perspective view of folder assembly 12 and fixationassembly 14. This system may be particularly useful in creating andapproximating at least a single fold of tissue from within the hollowbody organ. Such treatments may be effectuated for a variety ofmaladies; one particular malady in which such a system may be used isfor the treatment of GERD. Folder assembly 12, which is described belowin greater detail, may be comprised generally of acquisition assembly16, which may be used to initially acquire and approximate the tissue tobe folded. Acquisition assembly 16 may have a tensioning member 18 and apod member 20, each of which may be independently articulatable to forma first compact configuration and a second larger, expandedconfiguration. Each of tensioning member 18 and pod member 20 may beconnected to respective first and second actuation rods 22, 24 on thedistal end of a yoke member 26, as described in further detail below.

Acquisition assembly 16 may be located at the distal end of working body28 which may be configured as a flexible shaft having one or severallumens defined through the length of the working body 28. The workingbody 28 may be covered by a sheath or covering 30 to enhance thelubricity of the shaft as well as to maintain the interior of the body28 clear from body fluids and debris and provide a seal to allowinsufflation of the target organ. Various materials may be utilized forsheath 30 including various plastics, elastomers, latex, polyurethane,thermoplastics, e.g., PTFE, FEP, silicone, PVC, Tecoflex®, Pebax®, etc.,so long as they are preferably biocompatible.

A number of vacuum tubes 32 may also be routed through the length, or apartial length, of the working body 28 to acquisition assembly 16. Thefigure shows vacuum tubes 32 entering the working body 28 at itsproximal end. Alternatively, vacuum tubes 32 may enter working body 28at some distal point along the length of body 28 or vacuum tubes 32 mayenter working body 28 through handle 34. In either case, vacuum tubes 32may be positioned within one or several lumens defined through workingbody 28 and placed in fluid communication with pod member 20 tofacilitate in vacuum actuation of tissue, as further described below.The proximal ends of vacuum tubes 32 may be connected to one or morevacuum pumps (not shown). Furthermore, vacuum tubes 32 may utilizebraided materials, e.g., stainless steel, superelastic materials such asNickel-Titanium alloy, integrated throughout to prevent kinking orpinching of the tubes 32. Such vacuum tubes 32 may also accommodateinsertion of a snare or grasper type device that can be inserted oncetissue is acquired to mechanically grasp the invaginated tissue,depending on the type of tissue manipulation desired. An example of a“gooseneck” snare by Microvena, Inc. which may be used with the vacuumtubes 32 is described in further detail in U.S. Pat. No. 5,171,233,which is incorporated herein by reference in its entirety.

The proximal end of working body 28 is operatively connected to handle34. Also connected to handle 34 are first and second actuators 36, 38which may be used to actuate tensioning member 18 and pod member 20 fromthe first compact configuration to the second larger, expandedconfiguration. Each actuator 36, 38 may be actuated individually tocontrol a corresponding member independently of the other member or maybe actuated simultaneously, as described later herein. Main lumen 40 maybe defined throughout the length of working body 28 and through handle34 such that fixation assembly 14 may be advanced and withdrawn throughthe folder assembly 12. Fixation assembly 14 comprises, in part, staplerassembly 42 connected via flexible shaft 48 to a stapler handle 50.Stapler assembly 42 generally comprises staple cartridge 44, withinwhich one or more staples are housed. Stapler assembly 42 may also havean optional tapered distal end to facilitate insertion of the deviceinto or past tissue, as described in further detail below. Anvil 46 isin apposition to staple cartridge 44 and is used to provide a stapleclosure surface when tissue to be affixed is adequately positionedbetween staple cartridge 44 and anvil 46. With stapler assembly 42connected at the distal end of flexible shaft 48, handle 50 is connectedat the proximal end of shaft 48. Handle 50 may generally comprise ahousing and grip 52 in apposition to actuation handle 54. Handle 50allows for the surgeon or user to hold and manipulate fixation assembly14 with grip 52 while articulating stapler assembly 42 between an openand close configuration via actuation handle 54. Moreover, theconfiguration of handle 50 allows the surgeon or user to articulatestapler assembly 42.

When fixation assembly 14 is advanced within folder assembly 12, staplerassembly 42 is preferably in a closed configuration. When staplerassembly 42 has exited working body 28, staple cartridge 44 may bearticulated into an open configuration when positioned between yoke 26to receive the tissue folded between tensioning member 18 and pod member20. Stapler assembly 42 may then be advanced distally over the foldedtissue and clamped close over the tissue for deploying the staples. Toavoid damaging tissue surrounding acquisition assembly 16 and tofacilitate proper stapling, one or several insertion indicator(s) 56 maybe defined along a portion of flexible shaft 48 preferably near aproximal end of shaft 48, to aid the user in knowing when staplerassembly 42 may be safely articulated while fixation assembly 14 ispositioned within working body 28. Indicators 56 may be configured toalign with a proximal end of folder handle 34 to correspondinglyindicate, e.g., a position of fixation assembly 14 relative to folderassembly 10 when stapler assembly 42 may be opened, and/or how fardistally fixation assembly 14 may be advanced relative to folderassembly 10 to engage the folded tissue, etc. In addition to visualindicators, a mechanical indication, such as a stop or detent may beemployed to give the operator a tactile indication of “safe to open” and“safe to clamp” device positions.

A brief description of the acquisition assembly 16 will be given inorder to describe how the tissue may be manipulated by the devicesdescribed herein. A more detailed description will be given below.Perspective views of one variation of acquisition assembly 16 in an openand closed configuration are shown in FIGS. 2A and 2B, respectively.Tensioning member 18 may be comprised of tensioning arms 62, 64 whichmay extend longitudinally from a cross member. Each tensioning arm 62,64 may be configured to extend in parallel with one another and may beequal in length, as shown. Alternatively, arms 62, 64 may be staggeredin length and may also be angled relative to one another depending uponthe desired approximated tissue configuration, as described in greaterdetail below. The distal ends of tensioning arms 62, 64 may be bluntedor rounded to present an atraumatic surface to the tissue to beapproximated.

The pod member 20 may be comprised of a vacuum chamber or opening 60into which tissue may be drawn therewithin. A vacuum tube 76, as may beseen in FIG. 4A, leads to pod member 20. The opening of vacuum chamber60 may be slotted along a direction parallel to a longitudinal axis ofthe working body 28, or may be transverse to the parallel axis;alternatively, the opening may be defined a variety of shapes, e.g.,oval, elliptical, etc. One or both tensioning arms 62, 64 are preferablyconfigured to be parallel with vacuum chamber 60 and may have a lengthequal to that of vacuum chamber 60. Alternatively, the lengths oftensioning arms 62, 64 may be less than or greater than that of vacuumchamber 60. The distal end of the pod member 20 may have a flexibleand/or atraumatic tip 66 made from any number of polymers to facilitatethe guidance of acquisition assembly 16 into the hollow body organwithout damaging tissue along the way. The tensioning arms 62, 64 mayform a tissue receiving region 90 between the arms 62, 64 through whichtissue may be drawn and/or tensioned between the arms 62, 64.

In its compact configuration, tensioning member 18 and pod member 20 ofacquisition assembly 16 may each be shaped to compactly fit with oneanother. For instance, in this variation, tensioning arms 62, 64 may beconfigured to become adjacently positioned on either side of vacuumchamber 60. In alternative variations, tensioning arms 62, 64 may beconfigured to move relative to one another to alter the area of tissuereceiving region 90 between the arms 62, 64.

When tensioning member 18 and pod member 20 are actuated between an openconfiguration, as shown in FIG. 2A, and closed configuration, as shownin FIG. 2B, each of the members 18, 20 may be configured to maintain aparallel configuration relative to one another. Both tensioning member18 and pod member 20 may each be adapted to pivot on respective hingemembers 72, 74 such that in a first compact configuration, tensioningmember 18 and pod member 20 may be immediately adjacent to one another.In moving to a second expanded configuration, tensioning member 18 withtensioning arms 62, 64 and pod member 20 may be translated via actuationrods 22, 24, respectively, into opposing radial directions from oneanother relative to yoke 26, as shown in FIG. 2A. With tensioning member18 and pod member 20 in the open configuration, a tissue fixation region92 may be defined between the members 18,20, as further described below.FIGS. 4A and 4B show side views of an open and closed configuration,respectively, of the variation in which members 18, 20 may be configuredto maintain a parallel configuration relative to one another. FIG. 4Ashows members 18, 20 configured into an expanded configuration to definetissue fixation region 92 between the members, which are shown in thisvariation as being parallel to one another. FIG. 4B shows members 18, 20configured into the smaller delivery configuration where each of themembers 18, 20 are still parallel to one another.

A guidewire may optionally be used with the folder assembly 12 duringinitial deployment and positioning within the hollow body organ in amanner similar to a catheter for guiding acquisition assembly 16 to apredetermined position. Accordingly, an optional guidewire lumen may bedefined in atraumatic tip 66. As seen in FIG. 3, guidewire lumen 68 maybe defined through atraumatic tip 66 with guidewire 80 extending throughfrom guidewire opening 70 to guidewire opening 78. Guidewire openings70, 78 may both be defined on, e.g., atraumatic tip 66, to enableexchange of the guidewire through one or both tips; however, guidewireopenings 70, 78 may also be defined on other regions of pod member 20depending upon the type of exchange capability desired.

FIGS. 5A and 5B show tensioning member 18 and pod member 20 actuatedbetween an open configuration and closed configuration, respectively,with the atraumatic tip 66 removed. The attachment region 94 may be usedduring deployment without any attachments upon the region 94.Alternatively, various other devices aside from an atraumatic tip 66 maybe utilized for attachment to region 94. For example, components for usein drug delivery, dye marking, sensors for detecting various physicalparameters, etc., may be utilized and attached onto region 94.

FIG. 6 shows an end view of the acquisition assembly 16 in a closedconfiguration. As seen in this particular variation, tensioning arms 62,64 may be configured to align adjacently on either side of vacuumchamber 60 to form a compact configuration for delivery. Tensioning arms62, 64 are shown as being flush with a surface of vacuum chamber 60,however, tensioning arms 62, 64 may be sized in a variety of differentconfigurations and sizes as practicable for approximating tissue.

FIG. 7 shows a perspective view illustrating in one example how staplerassembly 42 may be advanced through the main lumen 40 of working body28. Once tensioning member 18 and pod member 20 have been actuated intoan open configuration (the approximated tissue is not shown forclarity), stapler assembly 42 may be advanced distally and manipulatedsuch that staple cartridge 44, within which one or more staples arehoused, and anvil 46 are in an open configuration ready to clamp overand fasten any approximated tissue which may be presented betweentensioning member 18 and pod member 20 in fixation region 92.

The vacuum force which may be used to draw in the tissue within vacuumchamber 60 of pod member 20 may be controlled through a number ofvarious methods. One variation is illustrated in FIGS. 8A to 8C, whichshow how valves 82 may be integrated into handle 34 for controlling thevacuum force. As seen in the cross-sectional side view of FIG. 8A, valve82 may be configured to rotate and align such that vacuum lumen 84 comesinto fluid communication with lumen 86, which leads to working body 28.Vacuum lumen 84 may be connected to a vacuum control unit (not shown),e.g., a standard luer assembly (QOSINA, model # 99720), to allow for airto be drawn through lumen 86 and create the vacuum at thedistally-located pod members. FIG. 8B shows how valve 82 may be rotatedby some degree, e.g., 45° relative to a longitudinal axis of handle 34,such that the vacuum force is no longer in fluid communication withlumen 86. FIG. 8C shows how valve 82 may be further rotated, e.g., 90°relative to a longitudinal axis of handle 34, such that lumen 86 is influid communication with venting lumen 88 to allow for venting of theassembly. A second valve, as shown, may be integrated in handle 34 toallow for the independent control of the vacuum force in a secondoptional pod member. Vacuum lumen 84 may be fluidly connected to acommon or independent vacuum pump. Moreover, rather than having twoindependently controllable valves 82, a single valve 82 may be utilizedto control the vacuum force in the pod member 20, depending upon thedesired results. The above variations are intended to be illustrativeand are not intended to be limiting in their scope of the disclosure inthe various possible configurations and methods available forcontrolling the vacuum force.

FIGS. 9A and 9B show the movement of tensioning member 18 and pod member20 relative to one another in reconfiguring the surrounding tissue. FIG.9A shows an end view of tensioning member 18 and pod member 20 whichhave been advanced while in a closed configuration into, e.g., astomach, and positioned adjacent to a region of interior tissue to bereconfigured. When desirably positioned, a vacuum force may be appliedwithin vacuum chamber 60 of pod member 20 such that tissue enters withinthe vacuum chamber or opening 60.

The different linings of the stomach, which include the mucosal layerMUC, muscular layer ML, and serosal layer SL, are shown incross-section. The vacuum force may be applied such that at least themucosal layer MUC of the tissue, e.g., an anterior wall AW and posteriorwall PW, is drawn into vacuum chamber 60 and the tissue is sufficientlyadhered to the pod member 20. While the vacuum force is applied,tensioning member 18 and pod member 20 may be translated away from oneanother in opposing direction such that the adhered tissue is drawnbetween the tensioning arms 62, 64 of tensioning member 18 and podmember 20 such that at least two adjacent folds of tissue are created toform an overlap region of tissue, as shown in FIG. 9B. Alternatively,rather than having both tensioning member 18 and pod member 20 moveopposite to one another simultaneously, one member may be heldstationary while the other member is translated radially. In anotheralternative, pod member 20 may acquire the tissue and tensioning member18 may be first translated and then pod member 20 may be subsequentlytranslated as a separate step to enhance tissue acquisition andpositioning. After the tissue has been acquired through any of themethods described above, the device may be curved or manipulated, asdescribed in further detail below. The tissue may then be affixedthrough one of the methods as described herein.

The methods described herein in acquiring a single, longitudinal fold,may be particularly effective for use in treatments such as GERD or toexclude certain portions of the wall of the body organ. In addition, thedevice can assist in the placement or revision (e.g. as a secondaryoperation or secondary step in a single procedure) of certain surgicalprocedures, such as a Roux En Y gastric bypass, or vertical bandedgastroplasty, or other restrictive procedures where the resulting pouchmay be stretched over time and may need further reduction. Further,certain procedures can lead to unforeseen results such as the formationof a gastric/gastric fistula. Such a fistula may be closed with thedevices and methods described herein. In a further example, the efficacyof the placement of a series of sutures or staples to form what istypically referred to as a “Collis” procedure, may be enhanced by theaddition of a tissue fold at the outlet of the “Collis” geometry, in thevicinity of the pylorus, or at any point along the resulting geometry tocreate resistance to food intake or enhance food dwell time in thegastric region. Examples of other treatments are described in furtherdetail in co-pending U.S. patent application Ser. No. 10/417,790, whichhas been incorporated by reference above. When the single tissue overlapis created by folder assembly 12, the overlap preferably includes anoverlap of at least the muscular layer ML and serosal layer SL to ensurea secure anchoring platform for the staples or fasteners to maintain thedurability of the tissue overlap. Such an overlap can also serve as away for securing an additional item within the organ such as pacingleads, sensors (e.g. monitoring of stretch receptors within thestomach), monitors, or other such diagnostic or therapeutic devices,including but not limited to those described in U.S. patent applicationSer. No. 10/215,070 filed Aug. 7, 2002, which is incorporated herein byreference in its entirety. A more detailed discussion may be found inU.S. patent application Ser. No. 10/188,547 filed Jul. 2, 2002, which isincorporated herein by reference in its entirety.

Folder Assembly

Folder assembly 12 may typically comprise a handle 34 at a proximal endof the assembly 12, as described above. Handle 34 may comprise housing110 which may enclose a pod actuation assembly within. FIG. 10A shows apartial assembly of handle 34 to illustrate the internal mechanisms. Asdescribed above, first actuator 36 may be used to manipulate tensioningmember 18 from a first configuration to a second configuration.Manipulation may be achieved, in part, by having first actuator 36connected via shaft 112 to transmit a torquing force to threadedcarriage shaft 114. The carriage shaft 114 is preferably free-floating,i.e., can translate longitudinally inside the shaft 112. Proximal mount116 may be free to rotate about the carriage shaft 114, but it ispreferably constrained to inhibit translation of mount 116 relative tothe carriage shaft 114. Distal mount 118 may be slidingly positionedover carriage shaft 114, typically by a threaded connection. Thisthreaded connection maintains a fixed relative distance between themounts so that the mounts and the carriage shaft 114 may translatelongitudinally as a unit. Proximal mount 116 and distal mount 118 may beanchored to the proximal ends of the actuation rod and tubing member,which houses the actuation rod, as described further below. Each mount116, 118 and shaft 112 may be configured to be free-floating, i.e.,translate longitudinally unconstrained, inside of shaft 112 within firstactuation channel 120 to accommodate the lateral movement of workingbody 28 and the subsequent translational movement of the proximal endsof actuation rods within housing 110. Stop 144, e.g., a ring or shoulderdefined upon shaft 114, may be positioned proximally of mount 116 toprevent the longitudinal movement of mount 116 along shaft 114. Mounts116, 118, however, may be configured to maintain a fixed distancerelative to one another when longitudinally translated as a unit.Corresponding mounts may be configured to translate along a second shaft(not shown) within second actuation channel 122 for a second actuationrod. Mounts 116, 118 may thus translate as a unit until actuator 36 isrotated.

The handle mechanism 34 helps to ensure that relative or unwantedmovement of the pods during flexing of the shaft of the folder inminimized or eliminated. Additionally, tubes 136, as further describedbelow, function so that the shaft of the device is not loaded duringactuation. These tubes 136 help to support the actuation load, but stillallow sufficient shaft flexibility.

As shown in FIG. 10B, which is a detail view of an exploded assembly ofmounts 116, 118 and their corresponding actuation rod assembly. Proximalmount 116 may have a rod anchoring region 130 defined along one side anddistal mount 118 may have tubing anchoring region 132 defined along oneside and collinearly with rod anchoring region 130. Actuation rod 140may be slidingly positioned within tubing member 136 and configured toslide longitudinally therewithin when translated relative to tubingmember 136 for actuating a pod member. Actuation rod 140 may be anchoredto proximal mount 116 by securely positioning actuation rod anchor 142within anchoring region 130. Likewise, tubing member 136 may be anchoredto distal mount 118 by positioning tubing anchor 138 within tubinganchoring region 132. Each mount 116, 118 may have collinearly definedopenings 134 to accommodate rod tubing 136 and actuation rod 140 whenthey are secured within anchoring regions 130, 132. As actuator 36 isrotated, carriage shaft 114 is rotated about its longitudinal axis tourge mount 118 towards or away from mount 116, as shown by the arrows,depending upon which direction carriage shaft 114 is rotated. Whenmounts 116, 118 are urged towards one another, actuation rod 140 isforced to slide distally within and relative to tubing 136 to urge thepod member, e.g., into its expanded configuration. Similarly, whenmounts 116, 118 are urged away from one another, actuation rod 140 isforced to slide proximally within and relative to tubing 136 to urge thepod member, e.g., into its compact configuration.

As further seen in FIG. 10A, main lumen 40 may be defined through alength of housing 110 to accommodate insertion of the fixation assembly14 therethrough. The proximal opening 128 of lumen 40 may be gasketed toallow for the insufflation of the hollow body organ using the device aswell as to prevent the leakage of bodily fluids and particles. Distalopening 124 may likewise be gasketed and is further configured to accepta proximal end of working body 28. The individual links 126 of onevariation of the proximal end of working body 28 are shown in the figureto illustrate an example of the mating between working body 28 andhousing 110.

An alternative variation on the folder assembly housing is shown in dualactuator assembly 150 in FIG. 11. In this variation, a side view ofhousing 152 is seen in which a single actuator or lever 158 may beutilized to manipulate both tensioning member 18 and pod member 20simultaneously. Lever 158 may be configured to rotate about pivot 160 tourge actuation link 162 to translate within actuation slot 164 tosimultaneously manipulate both members rather than having two or moreseparate controls. The proximal end of working body 154 may be seenconnected to housing 152 and vacuum tube 156 may be seen leading intoworking body 154 for communication with the folder assembly.

When lever 158 is depressed, actuation link 162 translates proximallinkage 155 within actuation slot 164. Proximal linkage 155 is free torotate about a pivot during flexure of the working body 154 and actuatesproximal blocks 153 to slide longitudinally within channels 151, whichare defined through housing 152. A spring or biased element 168 may bepositioned within slot 164 to place a biasing force on link 162 andlever 158 such that the assembly maintains a neutral or fixedorientation, if desired. Proximal blocks 153 are connected to actuationrods 157 which may extend distally through distal blocks 159 and furtherinto working body 154. Distal blocks 159 may be pivotally connected todistal linkage 163, which may be pivotally affixed to housing 152 viapivot 166 while allowing distal blocks 159 to translate within channels151. Tubing members 161 may be configured to allow passage of actuationrods 157 therethrough while remaining connected to distal blocks 159.Although the specific configuration of this variation is shown anddescribed, this is not intended to be limiting and is illustrative ofone variation of a handle which allows for single activation and tunablemechanical advantage.

The working body 28, which extends between the handle and the podassembly located at the distal end of the working body 28, may becomprised of a plurality of links or knuckles generally cylindrical inshape and positioned adjacently to one another, as shown and describedabove in FIG. 10A. A transition link or knuckle 170 is shown in FIGS.12A to 12C, which show side, end, and perspective views, respectively,of a link which may serve as a transitional link between the handle andthe length of the working body 28. As seen in the side view of FIG. 12A,transition link 170 may have a proximally located cylindrically-shapedflange 172 with a diameter greater than a diameter of the body portion176. Flange 172 may serve to help anchor the working body 28 to thehandle by fitting within a cavity defined in the handle and shaped toreceive flange 172. A transition portion 174 may taper a region of thelink 170 down to body portion 176. The end view in FIG. 12B shows mainlumen 178 defined through the length of link 170. Main lumen 178 may beshaped with parallel sides opposite to one another to allow fixationassembly therethrough in a specified configuration, as described belowin further detail.

Although the transition link 170 is shown to be generally cylindrical inshape, it may alternatively be configured in a variety of shapes, e.g.,ovular, elliptical, etc. Transition link 170 may also range in diameter,e.g., 0.75 in. (about 1.90 cm), so long as it is wide enough toaccommodate the insertion of fixation assembly 14 therethrough yet smallenough to be inserted into the body, e.g., through the esophagus. Link170 may also range in length, e.g., 1.125 in. (about 2.85 cm), dependingupon the desired design characteristics. Moreover, transition link 170may be made from a variety of materials, e.g., metals, plastics, etc.,so long as it is biocompatible. For example, transition link 170 may bemade from stainless steel, nickel-titanium alloys, or it may be moldedfrom plastics and thermoplastics, e.g., polycarbonate resins such asMakrolon® (Bayer Aktiengesellschaft, Germany).

FIGS. 13A to 13C show side, end, and perspective views, respectively, ofan example of a knuckle or link 180 which may be used to form at leastpart of the working body 28. This link variation 180 may be made from amaterial similar to that of transition link 170. It may also range indiameter, e.g., 0.69 in. (about 1.75 cm), so long as link 180 is wideenough to accommodate the insertion of fixation assembly 14 therethroughyet small enough to be inserted into the body, as above. Lumen 182 maybe configured such that it is keyed to allow fixation assembly 14 topass through in a specified configuration; thus, in this particularvariation, lumen 182 is shown as having straight walls 196, which may beparallel and opposite to one another. Link 180 may also define one ormore routing channels 184 around the circumference of the link 180 toallow for the routing of various wires or tubes therethrough along alength of working body 28. Link 180 shows a variation in which tworouting channels 184 may be defined on opposing sides around thecircumference. As further seen in FIG. 13A, link 180 may further defineperipherally located actuator rod lumens 196 and additional routinglumens 188 in link 180 outside of lumen 182. This variation shows atleast two of each lumen 186, 188 defined on opposing sides of link 180,although they may be defined elsewhere around link 180 in othervariations depending upon the number of lumens desired as well asspacing considerations.

FIG. 13B shows a side view of link 180 having least two protrusions 190extending from a first surface 192 on either side of the periphery oflink 180. Protrusions 190 may extend from first surface 192 at adistance, e.g., 0.040 in. (about 0.10 cm), so that when multiple linksare aligned with one another, protrusions 190 abut the second surface194 of an adjacent link, as shown in FIG. 13C. When multiple links arealigned, lumen 182, as well as actuator rod lumen 186 and additionalrouting lumen 188 may be aligned with adjacent links to form the overallmain lumen 40 and actuator rod lumen, as described above. Alternatively,overall flexibility of the device may be achieved by a single structurethat contains axial slots along its length, such as that shown in U.S.Pat. No. 5,685,868, which is incorporated herein by reference in itsentirety. Similarly, the working body may be formed of a single piece,flexible component, such as a polymer extrusion and/or multi-lumenco-extruded design, a braid, or other such known materials.

FIG. 13D shows an end view of link 180 in one variation where actuationrod 198 is routed through actuator tubing member 202 and both may bedisposed within actuator rod lumen 186 such that both extend through alength of working body 28. Vacuum tubes 200 may also be positionedwithin routing channels 184 and the entire assembly may be covered bysheath or lining 204, which may extend along at least a portion ofworking body 28, and preferably over the entire length of working body28. If a single pod member 20 having a vacuum chamber 60 is utilized,one of the two vacuum tubes 200 may be utilized. Alternatively, a secondvacuum tube 200 may also be utilized if the tensioning member 18 wereconfigured with openings for allowing a vacuum to be createdtherethrough or if a second pod member were utilized. Sheath or lining204, as mentioned above, may be used to enhance the lubricity of theworking body 28 as well as to maintain the interior of the body 28 clearfrom body fluids and debris and to provide sealing to enable insuflationof the target area. Various materials may be utilized for sheath 204including various plastics, elastomers, latex, polyurethane,thermoplastics, e.g., PTFE, silicone, PVC, FEP, Tecoflex®, Pebax®, etc.,so long as they are preferably biocompatible. Moreover, sheath 204 mayalso utilize braided materials integrated throughout to increasetensile, compressive, and/or torsional strengths of sheath 204 as wellas to provide for resistance against kinking or pinching betweenindividual links or when working body 28 is flexed.

FIGS. 14A to 14C show side, end, and perspective views, respectively, ofone variation of end link 210, which may be utilized as the terminal orfinal link of working body 28. End link 210, much like links 180, maydefine a keyed lumen 212, routing lumens 214, and actuator rod lumen218. Lumen 216 may also be defined and it may be counterbored toaccommodate a mechanical fastener for connecting the yoke member. As theterminal link, actuator tubing member 202 may be terminated and attachedto end link 210 at lumen 218 while allowing the actuator rod to extendthrough and beyond lumen 218 for attachment to the pod assembly. Sideand perspective views in FIGS. 14B and 14C further show detent 222,which may be defined along the end surface of link 210 for receivingand/or engaging the yoke member. Moreover, end link 210 may be made fromthe same or similar materials as described above for the other links.However, end link 210 is preferably made from a material such as ametal, e.g., stainless steel, or polycarbonate, which may withstandforces generated during pod and tissue manipulation. The end link 210,or a similar or additional link, may also be used to terminate anycovering placed over the working body 28 as heretofore described in FIG.13D.

FIG. 15 shows an end view of link 180 with staple cartridge 44 and anvil46 of fixation assembly 14 positioned within lumen 182 for advancementthrough working body 28. As seen, lumen 182 may be configured such thatit is keyed to allow fixation assembly 14 to pass through in a specifiedorientation. Walls 196, which may be parallel and opposite to oneanother, may thus be sized and configured to prevent fixation assembly14 from rotating about its own longitudinal axis within lumen 182 duringadvancement and deployment from the main lumen. Maintaining fixationassembly 14 in a predetermined orientation relative to working body 28and pod assembly 16 also helps to ensure that when staple cartridge 44and/or anvil 46 are actuated to open for clamping over folded tissue, aknown orientation of fixation assembly 14 relative to the folded tissueis maintained for tissue fixation. Other configurations for keying lumen182 to fixation assembly 14 may be available in other variations; theshape of lumen 182 and the cross-sectional shape of fixation assembly 14are not intended to be limiting but are merely illustrative of onepossibility of creating and/or configuring a keyed orientation betweenthe two assemblies.

A yoke member may be positioned at the terminal end of working body 28for holding and maintaining pod assembly 16. FIGS. 16A to 16C show top,cross-sectional side, and perspective views, respectively, of yoke 230.Generally, yoke 230 may be comprised of first arm member 232 and secondarm member 234 extending in parallel to one another from a base member242, which may be attached via proximal surface 244 to end link 210 ofworking body 28. Yoke 230 may terminate at each arm member 232, 234 infirst and second pivot regions 236, 238, respectively, about which thepod assembly 16 may be manipulated. First and second arm members 232,234 may further extend longitudinally with an overall length of about,e.g., 2 in. (about 5 cm), to create open region 240 between the armmembers 232, 234. First and second arm members 232, 234 may also betapered along their lengths to facilitate insertion of yoke 230 within atissue region. The opposing sides of each arm member 232, 234, which inpart defines open region 240, may be parallel to one another and arespaced apart, e.g., at 0.40 in. (about 1.0 cm), to provide clearance forstapler assembly 42 to be advanced therethrough. Furthermore, the opensides of region 240 may provide adequate clearance for stapler assembly42 to be opened for advancement over tissue to be affixed while armmembers 232, 234 help to maintain the orientation of stapler assembly 42relative to yoke 230 and working body 28.

The actuation rods for manipulating acquisition assembly 16 may extendthrough yoke 230 via first and second actuation rod channels 246, 248,which may be seen in the perspective view of yoke 230 in FIG. 16C. Aportion of actuation rod channels 246, 248 may be slotted or grooved andopen along an outer surface of each of arm members 232, 234 to allowactuation rods to extend past the outer surface during pod manipulation.FIGS. 17A and 17B show front and rear end views, respectively, of yoke230 to provide a detail view of actuation rod channels 246, 248 and openregion 240.

As mentioned above and as shown in the top view of staplercartridge/yoke assembly 250 in FIG. 18, each arm member 232, 234 may beparallel to one another and spaced apart to provide clearance forstapler assembly 42 to be advanced therethrough. The arm members 232,234 may function as guide surfaces 252, 254, respectively, to maintainstapler assembly 42 oriented in a predetermined configuration relativeto yoke 230. Furthermore, open region 240 may provide adequate clearancefor stapler assembly 42 to be opened prior to advancement over tissuewhile guide surfaces 252, 254 help to maintain the orientation ofstapler assembly 42 relative to yoke 230 and working body 28.Additionally, as shown in FIG. 18, clearance slots (open region 240) mayfunction to provide clearance for an endoscope or other tool, that canbe inserted and advanced or retroflexed to view the working device, asshown below in further detail.

To assist in alignment of the stapler assembly 42 to the target tissue,it may be desirable to vary the length of the open region 240. Asfurther shown in FIG. 19A, open region 240 may be configured with astop, cover, or extension 256 located adjacent to anvil 253 to constrainany transverse or lateral movement of anvil 253 while facilitatingmovement of cartridge assembly 251. Alternatively, if anvil 253′ isconfigured to move, stop or extension 258 may be configured adjacent tocartridge assembly 251′ to constrain any transverse or lateral movementof cartridge assembly 251′ while facilitating movement of anvil 253′, asshown in FIG. 19B.

From the distal end of each arm member 232, 234 of yoke member 230, ahinge member may be connected pivotally and extend distally where it maybe again pivotally connected to a pod member. An alternative angledhinge member 260 may be seen in FIGS. 20A to 20C, which show top, end,and side views, respectively. Angled hinge 260 may have a proximalportion 262 connected to a distal portion 264, which may be angled withrespect to either or both side surface 270 and top surface 272 ofproximal portion 262. A yoke-hinge pivot 266 may be defined at aproximal end of proximal portion 262 for pivotal connection to firstpivot 236 located on yoke 230. Similarly, a hinge-pod pivot 268 may bedefined at a distal end of distal portion 264 for pivotal connection toa pod member. Additionally, actuator rod channel 274 may be optionallydefined along at least a portion of proximal portion 262 to provide anopening or space for placement of an actuator rod. A second hingemember, which may mirror the configuration of angled hinge 260, may beconfigured for connection to second hinge 238 of yoke 230 for connectionto tensioning member 18. Moreover, angled hinge member 260 may be madefrom any variety of metals or thermoplastics, as described above.

Alternatively, a variation of a yoke/hinge assembly 280 may be utilized,as shown in the top views of FIGS. 21A and 21B. In this variation,yoke/hinge assembly 280 may be configured to flex via one or severaladditional pivots along its length. Additional ramp members 286, 286′,290, 290′, which may be extension members of yoke 282 having pivotedregions at both proximal and distal ends, may be joined via pivots 284,284′, 288, 288′, respectively, to one another to form elongated arms.Hinge members 294, 294′ may be connected via pivots 292, 292′,respectively, to ramp members 290, 290′, respectively, and have pivots296, 296′ located at their distal ends for connection to tensioningmember 18 and pod member 20.

Hinge members 294, 294′ may be actuated to an expanded configuration, asshown in FIG. 21A, and yoke/hinge assembly 280 may also be configured toflex via tensioning members (not shown) positioned within a lumen orslot defined along the length of assembly 280 in one or both arms. Thesetensioning members may be actively manipulated by the user from theirproximal ends. Thus, assembly 280 may be flexed to have a bend radius,as shown in the example of FIG. 21B, to allow access to various regionswithin the hollow body organ as well as to affix various configurationsof tissue. Alternatively, assembly 280 may also be passively flexed bycontact against tissue or via an external device, such as a mandrel, agripping tool, or endoscopes configured to flex the assembly 280. FIG.21C shows an example of a compact configuration of assembly 280 whichmay be utilized for deployment within a body.

In another variation, the folder assembly 12 may include a hinge deviceadapted to actively angle the acquisition assembly 16 in an offsetconfiguration. For example, the acquisition assembly 16 may be actuatedto rotate the tensioning member 18 and pod member 20 about respectivepivots such that the members 18, 20 may be offset at an angle, a,relative to a longitudinal axis of the working body 28. From this offsetconfiguration, tissue may be approximated and affixed at various angles.Alternatively, members 18, 20 may also be configured to be passivelyflexed by contact against tissue or via an external device, includingany of the tools described above. Furthermore, both members 18, 20 mayalso be offset at various angles depending upon the desired tissueconfiguration; moreover, each pod member may be also independentlyoffset at its own angle, again depending upon the tissue configuration.These examples are merely intended to be illustrative and are notintended to be limiting.

A top cover 372 which defines opening 374, as shown in FIG. 22A, may besecured over the vacuum chamber in pod member 20. An undercut 358 may bedefined around opening 374 to help aid in mechanically adhering anytissue which may be drawn into opening 374. Opening 374 is shown asbeing slotted; however, it may be formed into an elliptical shape orvarious other shapes so long as an adequate opening is available foradhering a sufficient amount of tissue therewithin or thereto.Alternatively, rather than a single opening 374, multiple smalleropenings may be defined over top cover 372 so long as an adequate areais available for adhering tissue thereto. An optional mesh-like insertmay be positioned within vacuum chamber 340 to help prevent the vacuumchamber from becoming clogged by tissue.

Turning to FIGS. 24A to 24D, an optional basket insert 360 is shown inside, end, bottom, and perspective views, respectively. Basket insert360 may be placed within the vacuum chamber to provide for an optimizedmesh surface through which a vacuum force may be applied to the tissue.Overall dimensions of basket insert 360 may vary so long as it may besecurely positioned within the vacuum chamber. An example of insert 360dimensions is 1.3 in. (about 3.3 cm) in length and 0.3 in. (about 0.8cm) in width. Basket insert 360 may also be made from a variety ofmaterials, e.g., stainless steel, provided that the tensile strength issufficient to withstand the various forces generated.

Basket insert 360 may have basket walls 362 forming a mesh-like vacuumchamber 370 with flange 364 surrounding the edges of one open side ofinsert 360. Each of the basket walls 362 may define a plurality ofopenings therethrough and the bottom surface of basket walls 362 mayalso define a plurality of supports 366 positioned in-between openings368. These supports 366 may be configured to space each of the basketwalls 362 away from the walls of vacuum chamber 340, as shown in FIG.22B, which shows a cross-sectional view of basket insert 360 positionedwithin vacuum chamber 340 and top cover 372 placed over the chamber 340.Plenum 376 may thus be defined around the entire basket insert 360, or aportion thereof, between basket walls 362 and vacuum chamber 340 via thespacing provided by supports 366 and flange 364. The open plenum 376allows a vacuum force to be applied to the tissue while preventing thetissue from clogging the vacuum chamber 340.

Alternatively, rather than utilizing a separate basket insert 360 forplacement within vacuum chamber 340, the interior surface of vacuumchamber 340 may be textured, channeled, labyrinthed, or interdigitatedto increase the surface area for vacuum adherence in the same manner asbasket insert 360. Moreover, mechanical tines or teeth may be formedwithin basket insert 360 or within vacuum chamber 340 to facilitateadditional mechanical adherence of tissue within the pod member. Anotheralternative may utilize a snare-like wire or member positioned withinvacuum chamber 340 around opening 374. In such a variation, once tissuehas been drawn through opening 374, the snare may be drawn tightlyaround the adhered tissue.

Moreover, one or both pod members may also incorporate a number of othermethods to facilitate tissue movement and/or adherence to the respectivepod member. For instance, FIGS. 23A and 23B show the top cover 372 andcross-sectional view of basket insert 360, respectively, of FIGS. 22Aand 22B with the addition of serrations 341. These serrations 341 areshown as being defined along a length of cover 372; however, they mayalternatively be defined around the opening 374 or in a number ofvarious other configurations depending upon the desired results.Furthermore, serrations 341 are illustrated as protrusions but anyvariations or configurations of serrations 341 may also be utilized inother variations of the device.

Fixation Assembly

The fixation assembly, as mentioned above, may be delivered through themain lumen of the folder assembly for deployment over tissue which hasbeen approximated into a folded configuration. One variation of astapler which may be used with the folder assembly described herein isdescribed in detail in U.S. Pat. No. 4,610,383 (Rothfuss et al.), whichis incorporated herein by reference in its entirety. Another variationof a stapler assembly 390, which is positioned at the distal end of thefixation assembly, is shown in side views in FIGS. 25A and 25B.Generally, stapler cartridge 392 may be pivotally connected via pivot396 to the end of flexible shaft 398. Anvil 394 may be configured toremain stationary relative to flexible shaft 398 while stapler cartridge392 may be manipulatable into an open and closed configuration withrespect to flexible shaft 398 and anvil 394. As seen, stapler cartridge392 and/or anvil 394 may optionally incorporate a tapered end 411positioned at a distal end of either cartridge 392, anvil 394, or both.Tapered end 411 may be fabricated of any of the polymers or othermaterials described herein and is preferably atraumatic to facilitatedilation or insertion past tissue. To manipulate stapler cartridge 392to open and close, a circular or disk-shaped cam 400 may be pivotallyattached about rotational pivot 402 located on the side of the proximalend of stapler cartridge 392. As seen in the detail view of cam 400 inFIG. 26A, actuation wires or cables 404, 406 may be wound about cam 400such that when cable 404 is pulled, cam 400 is urged to rotate aboutrotational pivot 402 in the direction of arrow 408. Actuation cables404, 406 may be manipulated from their proximal ends by the user. As cam400 is rotated in direction 408, a portion of anvil 394 may be engagedby cam 400 thereby forcing stapler cartridge 392 to pivot into an openconfiguration, as shown in FIG. 25B, when cam 400 is fully rotated, asin FIG. 26B. Cam 400 may be made into other shapes, e.g., oval,elliptical, etc., depending upon the desired design characteristics. Onecam 400 may be utilized, as shown; however, an additional cam may alsobe affixed on the opposite side of stapler cartridge 392 such that dualcams are configured to open and close simultaneously in parallel.Alternatively, in the same device, the location of stapler cartridge 392and anvil 394 may be reversed (e.g. anvil 394 may be configured to movetoward cartridge 392) depending on the location of the desired targetand clearance desired.

Detail views of the stapler assembly is shown in FIGS. 27A to 27D. FIGS.27A to 27C show cross-sectional side, front, and top views,respectively, of stapler assembly 410. Cartridge housing 412 generallyhouses a plurality of staples 414 which may be aligned adjacently to oneanother in one or more rows. The distal ends of both cartridge housing412 and anvil 422 may be configured to be atraumatic, e.g., blunted,rounded, etc., to the tissue to be affixed. Moreover, cartridge housing412 and anvil 422 may be configured such that their cross-sectionalshape is keyed to the main lumen of the folder assembly so that theorientation of the cartridge housing 412 is maintained relative to thefolder assembly, as described above.

FIG. 27C shows a top view of cartridge housing 412 wherein four rows ofstaples 414 may be aligned. Other variations of cartridge housing 412may utilize fewer or greater than four rows of staples 414. To deploystaples 414 from cartridge housing 412, two wedges 416, 416′, which maybe offset or staggered from one another, may each be pulled proximallythrough cartridge housing 412 via staple actuation wire 420. Wedges 416,416′ may be adjacently positioned to one another but are preferablystaggered such that the staples are deployed in a sequenced deploymentorder. Staple actuation wire 420 may be manipulated via its proximal endby the user when staples 414 are to be deployed out of cartridge housing412 into the tissue.

Staples 414 may be deployed through staple apertures 418 defined overthe surface of cartridge housing 412 in apposition to staple closuresurface 424 of anvil 422. As the staggered wedges 416, 416′ are pulledproximally, each wedge 416, 416′ may engage one or more rows of staplesand urge them through staple apertures 418, as shown in FIG. 27A, andthrough the tissue until they are engaged in corresponding stapledetents 426, as shown in FIG. 27D. As further shown in FIG. 27D, whichshows a top view of staple closure surface 424 of anvil 422, each stapledetent 426 preferably corresponds to the distal ends of each staple 414.

As described above, cartridge housing 412 and/or anvil 422 may beconfigured to be atraumatic, e.g., blunted, rounded, etc.; however, itmay be desirable to serrate or otherwise roughen the outside edges ofboth or either the cartridge 412 and/or anvil 422 to ensure full tissuecapture upon clamping of the two surfaces. A variation of the staplerassembly 410 is shown in FIG. 28, which shows serrations 428 definedalong the lengths of cartridge 412 and anvil 422. Serrations 428 may beoptionally defined along only one of cartridge 412 or anvil 422 and itmay also be defined only partially along the length. Alternatively,other projections or protrusions, such as spears, may be utilized. Inyet another alternative, rather than utilizing projections or serrations428, the surfaces of cartridge 412 and/or anvil 422 in contact with thetissue may simply be roughened or sharpened to facilitate serrating orroughening the contacted tissue or may employ absorptive materials inthe form of pads, coatings or covers to facilitate traction. Such pads,covers or coatings may be formed of cotton, Goretex®, polyester, Velcro,(see in particular Seamguard™ product (W. L. Gore and Associates,Flagstaff, Ariz.)), etc., and may remain on the surface of the cartridgeonce staples are delivery, or alternatively may be transmitted with thestaples to remain with the tissue affixed thereby.

To facilitate the deployment of the staples 414 as wedges 416, 416′ areurged through cartridge housing 412, staple pushers 430 may be utilized.As shown in FIG. 29A, which is a top view of one variation of staplepushers 430 positioned over corresponding staples 414, a single staplepusher 430 may be configured to engage two staples 414 in adjacent rows.When a wedge contacts a staple pusher 430, two adjacent staples 414 maybe fired sequentially. FIG. 29B shows a detailed perspective view of oneexample of a staple pusher 430. In this variation, staple pusher 430 maybe comprised of one or more sloped cam surfaces 432, 434 for slidinglyengaging a wedge. As a wedge engages a cam surface, it may push staplepusher 430 down towards staples 414 as pusher 430 is guided via one ormore guides 436, 438. Staple pusher 430 may then engage a first staplevia staple engagement surface 440 and a second staple via stapleengagement surface 442. An example of a wedge 446 which may beconfigured to slide within cartridge housing 412 is shown in theperspective view of wedge platform 444 in FIG. 29C. Although a singlewedge 446 is shown in the figure extending from platform 444, two offsetwedges may be configured into a single platform or two individual wedgesmay be utilized adjacent and offset to one another.

As mentioned above, cartridge housing 412 may be manipulated into anopen and closed position for clamping over the tissue. To control theclosure of cartridge housing 412 against anvil 422, a stapler controlhandle may be used, as shown in the cross-sectional views of the staplercontrol in FIGS. 30A and 30B. FIG. 30A shows stapler handle housing 450which may house the tensioning and releasing mechanism for opening andclosing cartridge housing 412 relative to anvil 422. Grip 452 may beprovided for the user to grasp while manipulating the device duringinsertion and deployment as well as to help articulate actuation handle454 for opening and/or closing cartridge housing 412. Actuation handle454 may be pivotally connected to housing 450 via pivot 458 and toactuation linkage 464 via handle pivot 460. When actuation handle 454 ispulled towards grip 452, handle 454 may rotate about pivot 458 and urgeactuation linkage 464 to rotate about handle pivot 460. The opposite endof actuation linkage 464 may be rotatingly connected via pivot 462 to atranslating slide block 466 contained within housing 450. Alternatively,it may be desirable to configure the fixation assembly with the staplejaws preferentially biased in an open position by placing tension onactuation cable 404 with a spring placed in device handle (not shown).Upon insertion of the staple jaws into the main lumen, the jaws may beretained in a closed position by the inner diameter of the main lumen.Upon reaching the yoke portion, the jaws would be adapted to bias openinto clearance slots 254 (252) to slide onto either side of presentedtissue. Once the fixation has occurred, the jaws of the fixationassembly may be directed to a closed position by the yoke, and then thedevice main lumen as the fixation assembly is withdrawn from thepatient.

Slide block 466 may anchor actuation cable 404 thereto via a mechanicalanchor 470, e.g., crimps, clamps, adhesives, etc. An upper surface ofslide block 466 may comprise rack 468 having a plurality of gear teethdefined thereon. When actuation handle 454 is pulled and actuationlinkage 464 is urged proximally, slide block 466 may be forcedproximally within travel guide 480, as indicated by arrow 488, tothereby pull actuation cable 404 proximally and thereby force cam 400 torotate and open the cartridge housing. Simultaneously, while slide block466 is translated proximally, rack 468 may engage and urge gear 484 torotate clockwise in the figure, which in turn may force gear 484 toengage and urge rack 474, which is located on a lower surface ofcomplementary slide block 472, to translate distally within travel guide478, as indicated by arrow 486.

Complementary slide block 472 may anchor actuation cable 406 thereto viaanchor 476 in the same or similar manner as anchor 470. Actuation cable406 may be attached to anchor 476 with a retention spring 482 optionallyinterposed between anchor 476 and slide block 472 to take up any excessslack in the cable 406. FIG. 30B shows the handle assembly afteractuation handle 454 has been actuated and slide blocks 466, 472 havebeen translated within their respective channels 480, 478 to fully orpartially clamp cartridge housing 412 against anvil 422 over the tissue.Once cartridge housing 412 has been clamped over the folded tissue,staple deployment actuator 494 may be rotated or urged to pull stapleactuation wires 420 to fire the staples into the tissue. Once stapledeployment has been completed, actuation handle 454 may be urgeddistally to reverse the process described above to open the clamp forremoval from the tissue region or for repositioning the staple assemblyin another region of the tissue.

The actuation cables 404, 406 as well as staple actuation wires 420 mayeach be routed through flexible shaft 456, which connects handle 450 tostapler assembly 410. Flexible shaft 456 may be comprised of a tubularmember having an outer sheath and an optional inner sheath, either orboth of which may be made from any of the polymeric materials describedabove. The shaft 456 may further utilize braided materials, e.g.,superelastic materials such as Nickel-Titanium alloy, integratedthroughout to increase column strength and to prevent kinking.Alternatively, shaft 456 may be formed of wire (round or square flatconfiguration) to enhance compressive and/or tensile strength.

In a further variation, although the tissue approximation device 500 maybe configured to be flexible, it may also be desirable to actively orpassively curve working body 502 to assist in overall placement of thesystem within the target organ for optimal presentation of tissueoverlap 100 prior to placement of the stapler assembly, as shown in theperspective views of FIGS. 31A and 31B. For passive actuation, a curvedstylet (not shown) may be placed alongside the actuation rods in theactuation rod channels, or in another available space within the workingbody 502, to bias the main body 502 in the curvature provided by thestylet. Working body 502 may be optionally configured to have a bendingregion 504 located proximally of the acquisition assembly 512. Thisoptional bending region 504 may be configured to facilitate bending of aportion of the working body 502 in any number of directions or only in aspecified direction, depending upon the desired results.

In addition, as depicted in the detail view of FIG. 31C, a distalposition control 507 may be adapted to fit onto working body 502 via aconnector tube 514. Distal position control 507 may be further adaptedto be integrated into handle 34 (as shown in FIG. 1). Distal positioncontrol 507 may comprise a base 506, a lever 508 configured to rotateabout pivot 510 located on base 506, a linkage mechanism 516, anadjustment assembly 518, and a curvature linkage 519. An optional cap orseal 517 may be placed over a proximal end of the base 506 to seal orcover an opening to the main lumen of the working body. In operation,lever 508 may be pivotally mounted to base 506 via linkage mechanism516. Depending on the amount of curvature desired in bending region 504,adjustment assembly 518 can be adjusted, e.g., by rotating the mechanismto adjust tension curvature linkage 519 prior to actuation of lever 508.FIG. 31A depicts the assembly 500 in the non-deployed, i.e., astraightened position of working body 502, while FIG. 31B depicts fullactuation of lever 508 to impart a curvature to the distal end ofworking body 28. The curvature of bending region 504 may accordingly beadjusted to any intermediate position depending upon the degree ofactuation of lever 508. Furthermore, although the degree of bending ofthe distal portion of the assembly 500 relative to a longitudinal axisof working body 502 is shown to be about 45° in this example, othervariations may be adjusted to have a maximum bend of a lesser or greaterdegree depending upon the desired bending. Moreover, other variationsmay allow for bending of the assembly 500 in either a uni-directionalmanner or in any other direction, again depending upon the desiredresults. It is further contemplated that the bending region 504 mayoccur at a variety of locations along the shaft of working body 502,such as in the distal or proximal region of the working body or at anypoint therebetween.

As mentioned above, optional cap or seal 517 may be placed over aproximal end of the base 506 to seal or cover an opening to the mainlumen of the working body. FIGS. 32A and 32B show perspective and endviews, respectively, of a variation of end cap or seal 517 which may beused to cap the handle of FIG. 31C. End cap 517 may seal the main lumenyet allow passage of devices through the membrane through a smallexpandable opening 523 covering the main lumen. An optional tab orhandle 521 may extend from the cap or seal 517 to facilitate handling ofthe cover. The cap or seal 517 may be formed from any of the polymericmaterials described herein, e.g., silicone.

FIG. 33 shows a variation 520 of how the tissue approximation assemblymay be utilized with other devices such as an endoscope 522. In thisexample, clearance slots (open region 240) may function to provideclearance for an endoscope 522, or other tool, that can be inserted intoand advanced through the main lumen 40 of working body 28. Before,during, and/or after tissue approximation, endoscope 522 may be advanceddistally out of main lumen 40 and advanced past acquisition assembly 16.A bending region 524 of endoscope 522 may then be retroflexed to viewthe results or progress of the tissue approximation and/or fixationusing an imaging system 526, e.g., optical fibers, CCD or CMOS imagingsystem, etc., positioned within a distal end of the endoscope 522.

FIG. 34 shows a portion of flexible shaft 456 of the fixation assemblyinserted through main lumen 40 of handle 110 in assembly 490. Handle 110is partially shown for clarity. As mentioned above, one or severalinsertion indicators 492 may be defined along a portion of flexibleshaft 456 at predetermined positions. These indicators are preferablylocated near a proximal end of shaft 456 to indicate information to theuser. For instance, when shaft 456 is aligned against handle 110 at oneparticular indicator, this may notify the user when it is safe forstapler assembly 410 to be opened in a patient body, e.g., whencartridge housing 412 is positioned proximally of the tissue between theyoke members. A second indicator defined along shaft 456 may indicate tothe user when the second indicator is aligned against handle 110 that itis safe to clamp stapler assembly 410 over the tissue, e.g., whenstapler assembly 410 is positioned fully over the approximated andfolded tissue thereby indicating that the cartridge housing 412 may beclamped against anvil 422 and the tissue for staple deployment.Additional indicators may be defined along shaft 456 to indicate variousother information, e.g., positional information such as how deep staplerassembly has been inserted relative to the folder assembly. Theseexamples are merely intended to be illustrative and are not limiting inhow indicators defined along the shaft 456 may be utilized.

Once the tissue has been affixed, stapler assembly 410 may be removedfrom the main lumen of the folder assembly and an endoscopic device maybe optionally inserted within the main lumen. The endoscopic device maybe outfitted with a visual imaging system, e.g., fiberoptic, CCD, CMOS,etc., to view the tissue region. If necessary, stapler assembly 410, orsome other tool, may be subsequently inserted through the main lumen toperform additional aspects of the procedure, or to complete theprocedure with the placement of additional fixation elements.

In describing the system and its components, certain terms have beenused for understanding, brevity, and clarity. They are primarily usedfor descriptive purposes and are intended to be used broadly andconstrued in the same manner. Having now described the invention and itsmethod of use, it should be appreciated that reasonable mechanical andoperational equivalents would be apparent to those skilled in this art.Those variations are considered to be within the equivalence of theclaims appended to the specification.

1. A method of acquiring and affixing tissue from within a hollow bodyorgan, comprising: passing a tissue acquisition assembly attached to aworking body transorally into the hollow body organ, the tissueacquisition assembly including a tissue adhering member and a tissuetensioning member, said tissue tensioning member seated on the tissueadhering member in a closed configuration; acquiring at least one regionof tissue from within the hollow body organ via the tissue adheringmember using vacuum, where the vacuum is positioned laterally and not ata distal end; articulating the tissue acquisition assembly at an angleoffset from a longitudinal axis of the working body, such that theacquired tissue is approximated through a tissue tensioning member toform a folded region of tissue between the tissue adhering member andtissue tensioning member; and affixing the folded region of tissue via acartridge assembly.
 2. The method of claim 1 further comprisinglaterally stabilizing the cartridge assembly via a yoke memberpositioned proximally of the tissue adhering member prior to affixingthe folded region of tissue.
 3. The method of claim 1 wherein affixingthe folded region of tissue comprises deploying a plurality of staplesfrom the cartridge assembly into the folded region of tissue.
 4. Themethod of claim 1 further comprising removing the cartridge assembly andinspecting the folded region of tissue via an endoscopic imaging devicepositioned adjacent to the folded region of tissue.
 5. The method ofclaim 1 further comprising removing the cartridge assembly andinspecting the folded region of tissue prior to affixing the foldedregion of tissue.
 6. The method of claim 1 further comprising removingthe tissue adhering member and tissue tensioning member from the regionof tissue.